Tibolone is an effective treatment for managing menopause symptoms. It provides relief from vasomotor symptoms like hot flashes and night sweats comparable to conventional hormone therapy. It also improves urogenital symptoms and has benefits for bone and sexual health. Tibolone has a lower risk of side effects like vaginal bleeding and breast pain compared to estrogen plus progestin therapy. It does not increase the risk of endometrial hyperplasia or breast cancer. Tibolone is a good alternative to conventional hormone therapy for managing menopause symptoms with fewer side effects.

1. The Menopause
Management Workshop
Menopause
H.R.T.
Moderator :- DR. SHARDA JAIN

2. Dr. Sharda Jain
MD(PGIMER), MNAMS, FICOG
FIMSA, DHM,QM & AHO
Director :-
Sec General : Delhi Gynae Forum

3. How
To
Handle
M
E
N
O
P
A
U
S
E

4. We all are Confused

5. In Last 15 years - this is my 15th
presentation

6. PRESENTATION is an ART , Not a science .
Which means It's Never perfect and can always improve.

10. Customer’s Place
Most Unhappy
Customer – learing

11. Put your self in a customer’s place
Most unhappy customer are
greatest source of learning

12. Menopause
 Menopause marks the end of
reproductive capacity of
women and results from the
permanent cessation of
ovarian function
 The median age for the onset of
menopause: 51.4 years
 Indian Context: 40.32–48.84
years
 By 2015, about 130 million
Indian women are expected to
live beyond menopause
Menopausal transition
Xu J, et al. J Am Board Fam Pract. 2005;18:374–382.
Umland ME. J Manag Care Pharm. 2008;14(3)(suppl S):S14–S19.
Sharma S, et al. JK Sci. 2007;9(1):13–17.
Aarti K. J Obst Gynecol India. 2011;323–326.

13. Menopause
Long Term Effects
Symptoms
Vasomotor Urogenital Mood /Cognitive
Osteoporosis Poor Bowel / Bladder Vision
H. Dis. Skin M.Tone

14. Complaints % western
women
West India North
India
Irritability 92 48 36
Lethargy 88 45 -
Depression 78 43 10
Flushes and night sweats 75 38 22
Headaches 64 27 15
Forgetfulness 61 60 65
Weight gain insomnia 51 60 70
How Common Are the various menopause symptoms

15. Relative frequency of climacteric
Symptoms in India
Symptoms India Incidence
Anklesaria
1995
Krishna
1995
Hot Flashes 30% 33%
Urinary Complaints 74% 35%
Vaginal Symptoms 56% 50%
Joint/ Muscle pain 20% 25%
Psychological 36% 20%

16. Treatmentof
Menopause
after
WHI
is never the same

17. WHI
Myths

18. Principles
•Time – Shortest possible
•Dose – Smallest possible
•Counseling – All short & long term risks
is mandatory
of HT

22. Redefining
TIBOLONE
in menopause

23. Structure and Mechanism of Action
 Tibolone is a selective tissue
oestrogenic activity regulator.
 Tibolone substitutes for the
loss of oestrogen production in
postmenopausal women, and
alleviates menopausal
symptoms.
 Tibolone prevents bone loss
following menopause or
ovariectomy
1960/70
Steckelbroeck S, et al. Mol Pharmacol.2004;66: 1702–1711.
Tibolone summary of product characteristics. Available at: www.medicines.org.uk.

24. Specific binding affinities of
tibolone and its primary metabolites

25. Tissue-Specific Effects of
Tibolone’s Metabolites
Modelska K, et al. J Clin Endocrinol Metab. 2002;87(1):16–23.
Palacios S. Eur Heart J Supplements. 2001; 3 (Suppl M): M12–M16.
+: Stimulatory effect;-: Suppressive effect; ?:
Unknown effect

26. Tissue-Specific Effects of Treatment Modalities
for Menopause: The Tibolone Edge
Tibolone Estrogen Estrogen+
progesterone
Raloxifene
(SERM)
Bone (BMD) + + + +
Climacteric symptoms + + + -
Vagina + - - +
Mood & libido ++ =/+ = =
Endometrium = - - =
Breast pain & density = - - =
Breast cancer = - - =/+
Venous thromboembolism = - - -
Myocardial infarction/stroke = - - =
STEAR: Selective, tissue estrogenic activity regulator ; SERMs: Selective estrogen receptor modulator.
+: Positive (beneficial effect); =: Neutral effect; -: Negative (detrimental) effect
Kloosterboer HJ. J Steroid Biochem Mol Biol.2003;83: 157–165.
The clinical profile of tibolone has advantages over
other treatment modalities

27. Effect of Tibolone on
Vasomotor and Urogenital
Symptoms of Menopause

28. Summary of Comparison of
Tibolone with Combine HT
Assessment
parameters
Tibolone vs. estrogen+progesterone HT
Vasomotor
symptoms
Comparable and significant reduction
inhot flashes, sweating and vaginal
dryness.
Better improvement in dryness of
skin with tibolone

29. Hot flushes: tibolone versus CHT (Comparable)
Baracat et al.Climacteric 2002
Control of vasomotor symptoms
*Significantly different from baseline; CEE, conjugated
equine estrogens; MPA, medroxyprogesterone acetate
Meanvalue
14
12
10
8
6
4
2
0
Baseline 3 6 9 13
*
* * * * * * *
Tibolone (n = 40)
CEE/MPA (n = 45)
Hot flushes
Treatment cycle

30. Clinical Evidence 1:
Tolerability Trial comparing
Livial vs E2 / NETA
Objective: To compare the efficacy and safety of tibolone vs. low-dose continuous combined
estradiol plus norethisterone acetate (E2/NETA) in healthy symptomatic postmenopausal
women (age: 45–65 years) (n=572).
Study Endpoints: Prevalence of vaginal bleeding, hot flushes and adverse events.
Study Results
 Comparable reductions in vasomotor symptoms
and vaginal atrophy in both the groups.
 Significantly lower incidence of vaginal bleeding
and breast pain/tenderness in the tibolone group.
Conclusion: Tibolone produced effective and
comparable reduction in menopausal
symptoms, and was associated with a lower
incidence of vaginal bleeding and breast
pain/tenderness vs. E2/NETA.
Hammar ML, et al. BJOG. 2007;114(12):1522–1529.

31. Tibolone
V/S HT
Urogenital
symptoms
Significantly lower incidence and
recurrence of vaginal bleeding/spotting
Significant improvement of lower vaginal
tract symptoms
Improvement in vaginal cytology

32. Clinical Evidence 2:
Long-Term Effects of Tibolone
on Urogenital Symptoms
Objective: To evaluate the effects of six years of tibolone therapy on the genital tract in
postmenopausal women (n=113).
Study Endpoints: Assessment of urogenital symptoms, vaginal epithelial activity and calculation of
vaginal karyopyknotic index and maturation index.
Study Results
 Significant improvement in the lower genital tract
symptoms in comparison to control.
 Significant increase in the karyopyknotic index and
maturation index in the tibolone group.
 Improvement in vaginal symptomatology with
minimal endometrial stimulation.
Conclusion: Tibolone was effective at
maintaining an inactive endometrium while
providing oestrogenisation of the lower
genital tract.
Morris EP, et al. Br J Obstet Gynaecol. 1999;106(9):954–959.

33. Assessment
parameters Tibolone vs.
Estrogen+progesterone (E+P) Raloxifene
Bone
Significantly greater increase in
lumbar spine, trochanter and total
hip BMD with tibolone
Significantly
greater increase
in lumbar spine
and total hip
BMD with
tibolone
Tibolone V/S HT (E + P) & Raloxifene
BONE

34. Clinical Evidence 1:
Study of Tibolone V/s raloxifene
Effects on osteoPenia (STEP)
Objective: To compare the efficacy of tibolone vs. raloxifene on BMD of the lumbar spine and
hip in osteopenic postmenopausal women (n=308).
Endpoints: Measurement of BMD, serum osteocalcin and serum type I collagen C-telopeptides
Study Results
 Larger increase in lumbar spine BMD after 1- and 2-
years and total hip BMD after 2 years of therapy
with tibolone vs. raloxifene.
 Comparable reductions in serum osteocalcin and
serum type I collagen C-telopeptides .
Conclusion: Tibolone prevented postmenopausal bone loss in older women and resulted in a
larger increase of BMD both at the lumbar spine and hip than raloxifene
Delmas PD, et al. Osteoporos Int. 2008;19(8):1153–
1160.
Tibolone vs.
raloxifene
p<0.01 for lumbar
BMD (1 y)
p<0.001 for lumbar
BMD (2 y)
p<0.05 for total hip
BMD (2 y)

35. Clinical Evidence 2: Long-term
Intervention on Fractures with
Tibolone (LIFT)
Objective: To assess the efficacy of tibolone in preventing bone loss and its effects on
fractures, breast cancer and cardiovascular disease.
Endpoints: Assessment of vertebral fractures and rates of cardiovascular disease and breast
cancer.
Study Results
 Increase in BMD of the spine and femoral neck in the
tibolone group.
 Decreased risk of vertebral and non-vertebral fractures
with tibolone.
 Decreased risk of invasive breast cancer and colon cancer
with tibolone therapy.
 Increased risk of stroke, but no difference in the risk of
coronary heart disease or venous thromboembolism with
tibolone vs. placebo.
Conclusion: Tibolone reduced the risk of fracture and breast cancer and possibly colon
cancer in older women with osteoporosis.
B Cummings SR, et al. N Engl J Med. 2008;359(7):697–708.

36. Summary of Effects of
Tibolone V/S HRT
SEXUAL
HEALTH
Improvement in sexual health and loss of
libido
Increased sexual frequency, satisfaction
and enjoyment
Significant reduction in SHBG
Increase in free testosterone levels
MOOD Improvement in mood

38. Clinical Evidence 2: Efficacy of Tibolone
vs. Conventional HRT on Sexual
Function
Objective: To compare the effects of TIBOLONE VS. CONVENTIONAL HORMONE
REPLACEMENT THERAPY on climacteric symptoms and sexual function in
postmenopausal women (n=140).
Endpoints: Evaluation of the GCS questionnaire and Rosen's FSFI. Measurement of
SHBG, FEI and FTI. Follow-up period: 6 months.
Study Results
 Comparable improvement in climacteric
symptoms.
 Greater improvement in the sexual subscore of
GCS in the tibolone group.
 Greater improvement in the desire, arousal and
orgasm sexual domains of the FSFI in the tibolone
group
 Greater and significant reduction in SHBG and
increase in FEI and FTI in the tibolone group.
Conclusion: Tibolone was found to be an effective alternative to conventional
HRT in the treatment of climacteric symptoms and sexual dysfunction in
postmenopausal women. Ziaei S, et al. Climacteric. 2010;13(2):147–156.
p<0.001 for tibolone vs.
CEE/MPA and control

39. ENDOMETRIUM
NO DIFFERENCE IN THE INCIDENCE
OF PROLIFERATION, ENDOMETRIAL
HYPERPLASIA OR CANCER
MORE FREQUENT AMENORRHEA
WITH TIBOLONE
Summary of Comparison of
Tibolone with
HRT ( E2/ NETA)

40. Clinical Evidence 1:
Tibolone v/S HRT
Histology on the Endometrium and Breast
Endpoints Study (THEBES)
Objective: To compare the endometrial safety of tibolone vs. CEE/MPA in healthy
postmenopausal women (n=3240)
Endpoints: Evaluation of the incidence of abnormal endometrial histology (hyperplasia or
carcinoma) and hyperplasia and carcinoma after 1 and 2 years of treatment.
Study Results
 No endometrial hyperplasia in the tibolone group.
 More frequent amenorrhea was reported with tibolone
1.25 mg (78.7%) and 2.5 mg (71.4%) than CEE/MPA
(44.9%).
 Low incidence of breast pain in the tibolone group.
Conclusion: Tibolone did not induce endometrial hyperplasia or carcinoma in
post-menopausal women, and was associated with a better vaginal bleeding
profile than CEE/MPA.
Archer DF, et al. J Clin Endocrinol Metab. 2007;92(3):911–918.

41. Key Take Home Messages—
Tibolone
Breast Cancer
Breast
Cancer
Effective in symptomatic
breast cancer patients,
with improvement in
quality of life*

42. Tibolone
&
Breast pain and density
Breast
pain &
density
Lower incidence/decrease in breast
pain/tenderness/mastalgia
No increase in mammographic density
of breast
Decrease in breast density scores
Decreased expression of
immunohistochemical markers

43. Tibolone Does Not Increase the
Mammographic Breast Density
Lundström E, et al. Am J Obstet Gynecol. 2002;186(4):717–722.

44. Clinical Evidence: Tibolone vs. 17β-Estradiol
in SURGICAL MENOPAUSE
Objective: To compare the effectiveness of tibolone and 17β-estradiol on climacteric symptoms
in surgically menopausal women (n=40)
Endpoints: Assessment of climacteric symptoms with Greene Climacteric Scale at baseline,
during washout and after the treatments.
Study Results
 Significant improvement from baseline in all
the subscale scores in both study groups.
 Improvement in psychological, somatic and
sexual subscales was significantly superior
in the tibolone group.
 Comparable relief of vasomotor symptoms
in both groups
Conclusion: Tibolone may improve mood, libido and somatic symptoms in surgically menopausal
women to a greater extent than estrogen therapy alone.
Somunkiran A, et al. Maturitas. 2007;56(1):61–68.

45. Clinical Evidence:
Effect of Tibolone on
Health-Related Quality of Life
Objective: To assess the improvements in HRQOL in menopausal women using tibolone
(n=100).
Endpoints: Assessment of change in HRQOL after 3 and 12 months of treatment.
Study Results
 Significant improvement in HRQOL
after 3 and 12 months of treatment
with tibolone.
 Maximal improvement was observed
in the somatovegetative subscale.
Conclusion: Tibolone was found to be effective in improving the overall HRQOL of
menopausal women. Somatovegetative symptoms showed most improvement.
Bhattacharya SM. Int J Gynaecol Obstet. 2007;99(1):43–45.
Somatoveget
ative
complaints
Psycholo
gical
complain
ts
Urogenita
l
complaint
s
Baseline 9.9 12.2 7
After 3
months
5.3 5 2.9
After 12
months
3.8 4.4 2.4

46. Golden Tips

47. Huang K-E, et al. Climacteric. 2010;13:317–327.
Key Take Home Messages—
Summary of Effects of Tibolone
Assessment
parameters
Summary of effects of tibolone
Vasomotor
symptoms
Significant and effective reduction in vasomotor symptoms
(hot flushes, vaginal dryness, sweating, and dryness of skin)
Urogenital
symptoms
Significantly lower incidence and recurrence of vaginal
bleeding/spotting
Significant improvement of lower vaginal tract symptoms
Improvement in vaginal cytology
Sexual health Improvement in sexual health and loss of libido
Increased sexual frequency, satisfaction and enjoyment
Significant reduction in SHBG
Increase in free testosterone levels
Mood Improvement in mood

48. Key Take Home Messages—
Comparison of Tibolone with
other Therapy Options
Assessment
parameters
Tibolone vs.
Estrogen+progesterone (E+P) Raloxifene
Bone Significantly greater increase in lumbar spine,
trochanter and total hip BMD with tibolone
Significantly greater
increase in lumbar
spine and total hip
BMD with tibolone
Endometrium No difference in the incidence of proliferation,
endometrial hyperplasia or cancer
More frequent amenorrhea with tibolone
-
Breast pain
and
Density
Significantly lower incidence of breast
pain/tenderness/mastalgia with tibolone
Greater increase in mammographic breast
density with E+P
Decrease in breast density score with tibolone
vs. increase with E+P
Decreased expression of
immunohistochemical markers with tibolone

49. Be Passionate and Exciting
Excitement is contagious- just like a Yawn

50. A Mediocre person tells.
A good persons explains
A superior person demonstrates
A great person inspires others
to see & makeup their mind for
themselves Harvey Mackey

51. Be
Clear
And
Direct

52. SURGICAL MENOPAUSE • Livial
• Miniasprin
• Esosteo
Recurrent Vag / UTI • Livial
• Rule out DM
• Neuro Dermatitis
• Local Oest. cream
Moderate to severe
Dyspareunia
• Livial
• Local estrogen
• Counseling of Couple

54. Answer Question Directly And clearly
If you are asked a question and you give a “POLITICIAN’S ANSWERS” – in other
words, if You Don’t answer the question – your credibility will decline,

57. Thank You

58. Hope Some Clarity is There !!

59. ADDRESS
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CONTACT US
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